Device and method for reducing calorie intake

ABSTRACT

Devices and methods for substantially reducing the caloric efficiency of the digestive tract by capturing food being digested in the stomach  10  and/or anywhere else in the gastrointestinal (GI) tract, absorbing or encapsulating the captured food into multiple capturing members and moving such multiple capturing members containing the ingestible encapsulated food down the GI tract, practically out of reach of the GI absorption organs, thus excluding the entrapped ingredients from being involved in the digestion and\or absorption process. The device is designed for oral delivery. The system can be comprised of liquid, food bars or a capsule system. The capsule system is comprised of an external capsule that dissolves in accordance with a temporal or ph dependent preset, which allows the food intake to be at least partially fluidic. The capsule system is further comprised of a mechanism designed to capture and isolate a portion of the food being digested.

CROSS-REFERENCE TO RELATED APPLICATIONS

This present application is a continuation of U.S. patent applicationSer. No. 11/581,175, which claims the benefit of PCT application no.PCT/IL05/00154 filed on Feb. 8, 2005, which claims the benefit of U.S.provisional application No. 60/542,843 filed on Feb. 10, 2004 all ofwhich are incorporated herein by reference in their entireties.

FIELD OF THE INVENTION

The present invention relates in general to a device and method forsubstantially reducing the caloric efficiency of the digestive tract bycapturing food being digested in the stomach and/or anywhere else in theGI tract, into entrapping members; moving the entrapping membercontaining said food down the GI tract, thus excluding at least part ofthe food intake from being absorbed in the small intestine and furtherdown the GI tract.

BACKGROUND OF THE INVENTION

Obesity is a chronic disease due to excess fat storage, a geneticpredisposition, and strong environmental contributions. This problem isworldwide, and the incidence is increasing daily. There are medical,physical, social, economic, and psychological comorbid conditionsassociated with obesity. There is no cure for obesity except possiblyprevention. Non-surgical treatment has been inadequate in providingsustained weight loss. Currently, surgery offers the only viabletreatment option with long-term weight loss and maintenance for themorbidly obese. Surgeries for weight loss are called bariatricsurgeries. There is no one operation that is effective for all patients.Gastric bypass operations are the most common operations currently used.Because there are inherent complications from surgeries, bariatricsurgeries should be performed in a multidisciplinary setting. Thelaparoscopic approach is being used by some surgeons in performing thevarious operations. The success rate—usually defined as >50% excessweight loss that is maintained for at least five years from bariatricsurgery—ranges from 40% in the simple to >70% in the complex operations.The weight loss from surgical treatment results in significantimprovements and, in some cases, complete resolution of comorbidconditions associated with obesity. Patients undergoing surgery forobesity need lifelong nutritional supplements and medical monitoring.

It is accepted that patients suffering from obesity are at asubstantially increased risk of medical ailments and a range ofdiseases, including: Type II diabetes, heart disease, stroke, high bloodpressure, high cholesterol, certain cancers, and other disorders.Furthermore, patients suffering morbid obesity have life expectancy thatis significantly reduced, by at least ten to fifteen years.

For patients suffering from extremely severe obesity (morbid obesity),i.e. for patients whose weight exceeds the ideal weight by at least 50kilograms, for example, it is absolutely essential to operate surgicallyon such patients in order to avoid not only a series of health problemsthat stem from such obesity, but also to avoid certain and imminentdeath of such patients.

It has also been observed that treatment based on a severe diet combinedwith a series of physical exercises associated with a change inbehavior, in particular eating behavior, are relatively ineffective insuch cases of morbid obesity, even though such methods of treatment arethe most healthy.

Methods that have been used in the prior art to treat obesity includegastric bypasses and small-bowel bypasses such as described in U.S. Pat.No. 6,558,400 and U.S. Pat. No. 6,543,456. The number of these bariatricsurgeries has skyrocketed from 40,000 per year back then to 120,000 in2002. Many complications are associated with these procedures. Manypatients have suffered serious side effects and regret having had it.

Other methods aim at reducing the effective volume of the stomach toinduce a satiety feeling by the patient and hence reducing the calorieintake per meal.

One such method is the stapling of portions of the stomach has also beenused to treat obesity, such as described in U.S. Pat. No. 5,345,949.This includes both vertical and horizontal stapling and other variationstrying to reduce the size of the stomach or make a small stoma opening.Many problems have been associated with the use of staples. First,staples are undependable; second, they may cause perforations; and thepouch or stoma opening formed by the staples becomes enlarged over timemaking the procedure useless.

Another method that has been developed is the placement of an inflatablebag or balloon into the stomach causing the recipient to feel “full”.Such a procedure has been described in the patent to Garren et al U.S.Pat. No. 4,416,267. The balloon is inflated to approximately 80% of thestomach volume and remains in the stomach for a period of about threemonths or more. This procedure, although simple, has resulted inintestinal blockage, gastric ulcers, and even in one instance, death andfails to address the problems of potentially deleterious contact withthe gastric mucosa which can result from leaving an inflated bag in thestomach for an extended period of time. Moreover, it also failed toproduce significant weight loss for long periods of time.

Yet another method employs the placement of a band around a portion ofthe stomach thereby compressing the stomach and creating a stoma openingthat is less than the normal interior diameter of the stomach forrestricting food intake into the lower digestive portion of the stomach.Kuzmak et al in U.S. patent have described such a band. U.S. Pat. No.4,592,339. It comprises a substantially non-extensible belt-like strap,which constrictively encircles the outside of the stomach therebypreventing the stoma opening from expanding. Kuzmak et al also describebands, which include a balloon-like section that is expandable anddeflatable through a remote injection site. The balloon-like expandablesection is used to adjust the size of the stoma opening bothintra-operatively and post-operatively.

Complications have been observed with both inflatable and non-inflatablegastric bands. In particular, obstruction of the stoma from edema andmigration of the band has been observed. Such edema-caused obstructionof the stoma may be due to excessive vomiting. In these cases, the stomamust be enlarged either by deflating the expandable portion of a band orby removing the band altogether.

Yet another method is to impose satiety. U.S. Pat. No. 6,677,318,describing a swellable sponge-like structure. These structures areswallowed by the patient being collapsed inside a capsule. The capsuledissolves in the stomach and the polymer structure with super absorbingcharacteristics; absorb the gastric juices, which cause the structure toswell considerably. This patent aims to reduce food intake by causingthe recipient to feel “full”, yet the absorbed content of the sponge isfinally digested.

Lipase inhibition as a mean for reducing lipid intake is well known inthe art, the major draw back is the oily stool as a side effect. Toovercome this side effect, polymers capable of absorbing lipids whereintroduce, as in U.S. Pat. No. 4,432,968, but as the absorption isreversible and shifted backwards as a result of bile salt emulsifier,the overall entrapment was quite poor.

In order to overcome the a forth mentioned drawbacks, the presentinvention relates on a lipid absorption polymer having an prolongedequilibrium period in the range of 4-8 hours so as to keep theabsorption step active during the relevant period in the digestiontract.

It is then the object of this invention to overcome these and otherdeficiencies described above.

SUMMARY OF THE INVENTION

The invention seeks to provide a successful and non-invasive alternativeto existing approaches for controlling obesity.

The invention objective is to substantially reduce the caloricefficiency of the digestive tract by capturing food being digested inthe stomach and/or anywhere else in the GI tract into entrappingmembers; moving the entrapping member containing the entrapped foodingredients down the gastrointestinal tract, thus excluding at leastpart of the entrapped food from being absorbed in the small intestine.

Another objective of this invention is to introduce a lipid absorptionpolymer having an prolonged equilibrium period in the range of 4-8 hoursso as to keep the absorption step active during the relevant period inthe digestion tract.

Another objective of this invention is to interfere with the micellesformation and capture the free lipids contained within.

Another objective of this invention is to provide a delivery system ofthe material via means of compressing the material so that it takes lessspace in the intake, and when the capsule, for example, opens up ordissolves, the individual particles of the material expand toaccommodate the captured liquids.

In one embodiment, the device is comprised of a capsule system for oraldelivery. The capsule system is comprised of an external capsule made ofgelatin—as an example that dissolves in accordance with a temporalpreset, which allows the food intake to be at least partially fluidic.The capsule system is further comprised of an internal permeable baghaving a structure such as meshed, woven or fibers, made ofdisintegrable material such as gelatin for example, which bag containexpandable, super absorbent beads, which dry beads are larger than thepores of the bag, which bag is inflatable. When the bag comes in contactwith the fluidic content of the stomach, fluids penetrate into the bag.The fluids are absorbed by the expandable, hydrogel beads enclosed.These beads expand partially or until they reach the absorption capacitylimit. Optionally, the internal bag further contains a coating capsule,which dissolves at this time and coats the expandable beads, to sealsand protects them from disintegration or prevent leakage of entrappedliquid, throughout their journey out of the GI tract.

For the sake of clarity, a capsule is a sealed container and a hag is apermeable containers.

In other embodiments, the external capsule contains folded mechanicalstructures, which open up to captures some of the stomach content andprotects them from disintegration throughout their journey through andout of the GI tract.

Further scope of applicability of the present invention will becomeapparent from the detailed description given hereinafter. However, itshould be understood that the detailed description and specificexamples, while indicating preferred embodiments of the invention, aregiven by way of illustration only, since various changes andmodifications within the spirit and scope of the invention will becomeapparent to those skilled in the art from this detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will become more fully understood from thedetailed description given herein below and the accompanying drawings,which are given by way of illustration only and thus not limitative ofthe present invention.

FIG. 1 is a view of the assembled device.

FIG. 2 a is a view of the external capsule.

FIG. 2 b is a view of the internal bag.

FIG. 2 c is a view of an expandable bead.

FIG. 2 d is a view of a coating capsule.

FIG. 3 illustrates a basic embodiment of this invention depicting anouter capsule containing super absorbent expandable beads.

FIG. 4 a illustrates of the capsule system entering the stomach at t1.

FIG. 4 b illustrates the external capsule dissolving at t2.

FIG. 4 c illustrates the expandable beads expanding as they absorbstomach fluids.

FIG. 4 d illustrates the expandable beads reaching the size limits ofthe internal bag at t4.

FIG. 4 e illustrates the rupture of the coating capsule at t4.

FIG. 4 f illustrates the internal capsule dissolving at t5.

FIG. 4 g and FIG. 3 h illustrate the draining stage of the coated at t6.

FIG. 5 is a temporal illustration of a full cycle of the process.

FIGS. 6 a-d illustrates another embodiment of the invention.

FIGS. 7 a-c illustrates another embodiment of the invention.

FIGS. 8 a-c illustrates yet another embodiment of the invention.

FIG. 9 illustrates an embodiment for loading the force into the smallstructures.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Before explaining embodiments of the invention in detail, it is to beunderstood that the invention is not limited in its application to thedetails of construction and the arrangement of the components set forthin the following description or illustrated in the drawings.

Unless otherwise defined, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. The materials, methods, andexamples provided herein are illustrative only and not intended to belimiting.

In accordance with one basic embodiment of the present invention,illustrated in FIG. 3, the device is in a form of a pill comprises anouter capsule 200 made of Gelatin for example, which capsule 200 is atleast partly filled with cross-linked polymer beads, such as Hydrogels,supper absorbent polymers, cross-linked polymers, known in the art,which beads having a diameter in the range of microns to few mm and aremade of non toxic and non digestible polymer and are capable ofabsorbing fluids at a ratio of at least 5:1 (W/W), (liquid\bead) bydiffusion, osmotic force, ionic interaction, and\or capillary force,and\or magnetic force, or other physic-chemical mechanism, such aspolyacryl amid derivatives, which absorbing beads may also act as ionexchanger, exclusion gel such as a cross-linked polydextran (or possiblyCellulose Ethers like material), which beads optionally may also containfunctional groups that improves permeability when the ambient is acidic(low pH—at the stomach), yet the permeability is reduced when theambient pH is neutral or basic (small intestine).

In practice, the pill is ingested, and the capsule 100 dissolves at atemporal preset, beads 300 which are now in contact with the content ofthe food being digested, absorbs caloric enriched liquid and swells.Next the beads along with content of the stomach 10 are moved into thesmall intestine, where the entrapped content of the beads arepractically not involved in the digestion and absorbing steps in theintestine. It is plausible to design the beads such that they willcontinue to absorb digested food in the small intestine and further downthe GI tract.

In another embodiment, similar to the first embodiment, the beads arepre coated or pre absorbed by a composition capable of forming at leasta partial nutrient barrier on small intestine. The composition helpsfurther to reduce the absorption of food in case of leaking from thebead.

FIG. 1 is a view of the assembled capsule system. It comprises anexternal capsule 100 which can be made of a biocompatible material suchas gelatin, an internal bag 200 which can be made from gelatin with anet like structure, absorbing beads 300 which can be made from Hydrogelsand coating capsule(s) 400.

FIG. 2 a illustrates the opened external capsule, which opens into twohalves 201 and 202 at time t2 (see FIG. 5). It cans also dissolve withcontrol thickness or any other known technique.

FIG. 4 a illustrates the assembled capsule being swallowed by thepatient at time t1 (see FIG. 5) which is a while after he started hismeal at time t0 (see FIG. 5). FIG. 2 b is a view of the internal bag200, FIG. 2 c is a view of an expandable bead 301 and FIG. 2 d is a viewof a coating capsule 400.

FIG. 4 b illustrates the dissolution of the external capsule in thestomach 10 at time t2. At this time the super absorbing expandable beads300 are exposed to the stomach 10 fluids and start absorbing them, asillustrated in FIG. 4 c and continue at time period t3 (see FIG. 5).

Optionally, after the expandable beads 300 fill out the space allowed bythe internal bag 200, as illustrated in FIG. 4 d, they press against thecoating capsule(s) 400. This triggers at time t4 (see FIG. 5) therupture, as illustrated in FIG. 4 e, or dissolution of the coatingcapsule(s) 400, which contains an agent that coats and seals (see FIG. 4f) all the expandable beads such that they and their content remainsuntouched throughout their migration down the GI tract.

Once all the expandable beads 300 are coated, at time t5 (see FIG. 5),the internal bag dissolves, all the expandable beads are free to moveabout the GI tract, at time period t6 (see FIG. 5), and they are draineduntouched through and out of the GI tract, as illustrated in FIGS. 4 gand 4 h. The expandable beads 300 dissolve after a preset number ofdays, in case they were not able to clear out of the GI tract. Inanother option, the patient drinks a liquid that dissolves expandablebeads 300.

Thus the content of the expandable beads 300 which contains ingestedfood remains untouched, is not digested and absorbed by the body andhence reduces the calorie efficiency of the meal.

In another embodiment of this invention, time t5 (see FIG. 5), when theinternal bag 200 dissolves and the expandable beads 300 are free to moveabout the GI tract, occurs only after the fed mode of the stomach 10 isfinished, and the stomach 10 goes into its maintenance mode.

In another embodiment (not shown) the fluids pass on their way to thesuper absorbable beads through a filter which is wide on the outer sideand narrow in the inner side. This makes it easy for the fluids the flowinward the beads and hard to flow back.

In yet another embodiment of this invention, a polymer capable ofabsorbing lipid having an prolonged equilibrium period in the range of4-8 hours so as to keep the absorption step active during the relevantperiod in the digestion tract, is provided. One such polymer for exampleis Polypore, having high absorption ratio of 13 gr lipid to 1 grpolymer.

Another embodiment of the present invention is to interfere with themicelles which are necessary for the lipid digestion activity. Thepurpose of the polymer is to disassemble the micelles and extract thelipids. Such a polymer is, for example, isss Gantrez® series, especiallyGantrez 225 and Gantrez 425.

So when a mixture of Polypore and Gantrez are introduced to the smallintestine, the Gantrez will interfere with the micelle formationequilibrium, and the polypore will absorb the free lipids without thehighly competitive back extraction mechanism.

Another embodiment of this invention is illustrated in FIGS. 6 a-6 d inthis embodiment the inner bag is in the form of a folded basket 202which contains a stack of spheres 500 each of which is split into tohalves 501 and 502 which are connected by a spring like connection 503that the force embedded in it will close up the spheres to the poison504 in a relaxed mode. When the external capsule 100 dissolves, theforce embedded in the stacked up halve spheres 500 will cause theoptional basket 202 to open up optionally locked into the positionillustrated in FIG. 6 d. This allows the half spheres to close up toposition 504 which scoops up the food being digested while closing up.The sphere 504 is now small enough to leave the basket 202 through theopening 203, being pushed by the next pair of half spheres. The lastpair of half spheres in the stack may remain in the basket 202, whichdissolves after a preset time and clears out down the GI tract. Theoptional basket 202 is designed to avoid the possibility that theclosing sphere will harm the stomach 10 inner walls. The spheres 500 areof a size appropriate to be able to travel through the GI tract. Theclosed spheres are made of a substantially ingestible biocompatiblematerial and remain closed and untouched through the journey down andout of the GI tract. The spheres 500 dissolve after a preset number ofdays, in case they were not able to clear out of the GI tract. Inanother option, the patient drinks a liquid that dissolves spheres 500.

Another embodiment of this invention is illustrated in FIGS. 7 a-7 c. Inthis embodiment, the capsule is filled up with number of folded stentlike structures 600. When the external capsule 100 dissolves, a forcewill cause the stents 600 to open up and lock into the positionillustrated in FIG. 7 c. The force can be embedded in the structures600, apply via external or internal spring (not shown) or generatedinternally or externally via chemical reaction with the stomach 10content. While stents 600 open up inside the stomach 10 they will suckup some of the content into the stents. The stents 600 are built suchthat they have entry holes 604 through which the content is sucked up.Optionally, entry holes 604 are equipped with a directional valve suchthat the stomach 10 content can only enter into the stents but can notescape. The size of the opened stents 600 is designed to be able totravel through the GI tract. The stents are made of a substantiallyingestible material and remain closed and untouched throughout theirjourney down and out of the GI tract. The folded structures 601, 602,603 can also he polymer beads and the force applied to them beforedelivery to compress the beads substantially so that they open insidethe GI tract to capture various liquids. One such polymer, for example,is Polypore, having high absorption ratio of 13 gr lipid to 1 gr polymerand high ratio of its free form volume to its compressed form volume.

In another embodiment the force (such as spring force or elastic force)is being loaded into the small structures 700 before using the capsule.FIG. 9 shows a device 800 for compressing the small structures 700 andencapsulating them to form the pill to be swallowed. Turning the handle802 in direction 806 moves the bar 804 in direction 808. The capsulehalf 101 is pushed towards the second half 102 and the small structures700 are compressed. This will overcome the possibility that the forcewill deteriorate over time.

Another embodiment of this invention is illustrated in FIGS. 8 a-8 c. Inthis embodiment, the capsule is filled up with a number of foldedstructures 700. When the external capsule 100 dissolves, the forceembedded within the structures will cause the structures 700 to open upinto the position 702 illustrated in FIG. 8 c. The force can be embeddedin the structures 700, in the manufacturing process by taking a semirigid structure and forcing it into a collapsed form by applyingpressure. The kinetic energy stored in the structures 700 will be usedto restore the structures into their natural form once the capsule 100has opened up. This force is designed so that it can over come thepressure inside the stomach 10. While structures 700 open up inside thestomach 10 they will suck up some of the content into the structures700. The structures 700 are made up such that they have entry holes 703through which the content is sucked up. Optionally, entry holes 703 areequipped with a directional valve such that the stomach 10 content canonly enter into the structures 700 but cannot escape. The size of theopened stents 700 is designed to be able to travel through the GI tract.The full structures 700 are made of a substantially ingestible materialand remain closed and untouched throughout the journey down and out ofthe GI tract.

In another embodiment the folded structures are polymer beads and theforce applied to them before delivery to compress the beadssubstantially so that they take less space on the intake but open insidethe GI tract to capture various liquids. One such polymer, for example,is Polypore, having high absorption ratio of 13 gr lipid to 1 gr polymerand high ratio of its free form volume to its compressed form.

The invention being thus described in terms of several examples andembodiments, it will be obvious that the same may be varied in manyways. Such variations are not to be regarded as a departure from thespirit and scope of the invention, and all such modifications as wouldbe obvious to one skilled in the art are intended to be included withinthe scope of the following claims.

1. A method for containing a volume within the digestive tractcomprising: releasing a self-opening barrier in the digestive tract,wherein the releasing comprises opening the barrier, and wherein openingcomprises sucking contents of the digestive tract into the self-openingbarrier.
 2. The method of claim 1, wherein the element comprises astent-like structure.
 3. The method of claim 1, further comprisingclosing the self-opening barrier.
 4. The method of claim 1, wherein thebarrier comprises an entry hole, and wherein sucking contents comprisessucking contents through the entry hole.
 5. The method of claim 1,wherein the barrier comprises a directional valve in the entry hole. 6.The method of claim 1, further comprising retaining the contents of thedigestive tract in the self-opening barrier, wherein the stomach contentdo not escape the self-opening barrier.
 7. The method of claim 1,further comprising journeying the barrier throughout and out of thedigestive tract.
 8. The method of claim 7, further comprisingmaintaining the barrier in a closed configuration when the barrierjourneys throughout and out of the digestive tract.
 9. The method ofclaim 1, wherein the barrier comprises a polymer.
 10. A device forcontaining a volume within the digestive tract comprising: aself-opening barrier comprising a stent-like structure, wherein thebarrier comprises an entry hole configured to allow the passage ofcontents of the gastrointestinal tract through the entry hole, andwherein the entry hole comprises a directional valve.
 11. The method ofclaim 1, wherein the barrier comprises a polymer.
 12. The method ofclaim 1, wherein the barrier is dissolvable within a few days in the GItract.
 13. The method of claim 1, wherein the device contains at least 5times of the device weight.
 14. A method of containing a solid elementwithin the digestive tract comprising: delivering a first malabsorptiondevice to the digestive tract, wherein the first malabsorption devicecomprises a first element having a first element opening and a firstelement volume, and a second element having a second element opening anda second element volume; closing the first malabsorption device from afirst configuration to a second configuration, wherein the first elementis flexibly attached to the second element, wherein the device has afirst configuration wherein the first element opening is away from thesecond element opening, and the device has a second configurationwherein the first element opening is directly adjacent to the secondelement opening such that the first element volume and the secondelement volume are contiguous.
 15. The method of claim 14, wherein thefirst element volume forms a closed volume with the second element. 16.The method of claim 14, wherein the closing further comprises scoopingup food with the first element.
 17. The method of claim 14, whereindelivering comprises stacking a first malabsorption device on a secondmalabsorption device into a stack, and sending the stack to the stomach.18. The method of claim 17, wherein the stack comprises a dissolvablecovering.
 19. The method of claim 18, wherein the dissolvable coveringcomprises a capsule.